1. Field of the Invention
The instant invention relates generally to compositions for treating the symptoms of asthma in a human patient, and specifically to an orally administered composition derived from natural sources for treating the symptoms of bronchial asthma.
Bronchial asthma is a relatively common lung disorder characterized by periodic attacks of wheezing alternating with periods of relatively normal breathing. While bronchial asthma is usually intrinsic (no cause can be demonstrated), it is occasionally caused by a specific allergy (e.g., pollen, mold, dander, dust). Although most individuals with asthma will have some positive allergy tests, the allergy is not necessarily the cause of the asthma symptoms.
Symptoms can occur spontaneously or can be triggered by respiratory infections, exercise, cold air, tobacco smoke or other pollutants, or by allergies to foods, drugs or other irritants, such as chemicals, dust mites, feathers, food additives, fumes, mold, animal dander, and the like. Other things can also trigger asthmatic episodes: anxiety, fear, laughing, stress or anxiety, low blood sugar, adrenal disorders, temperature changes, extremes of dryness or humidity, or respiratory infections. The muscles of the bronchial tree become tight and the lining of the air passages become swollen, reducing airflow and producing a wheezing sound. Mucus production is generally increased.
With regard to the typical symptoms, wheezing usually begins suddenly, is often worse at night or in the early morning, is commonly aggravated by exposure to cold air, sudden exercise or both, and sometimes resolves itself spontaneously. In many patients, wheezing is accompanied by a cough with sputum (phlegm) production containing mucus (mucoid sputum). In severe cases, there may be extreme difficulty breathing, a bluish color to the lips and face, severe anxiety which can result in a dangerous positive feedback effect, rapid pulse and/or sweating.
Typically, the afflicted individual breathes relatively normally most of the time, but will have periodic attacks of wheezing. Asthma attacks can last minutes to days, and can become dangerous if the airflow becomes severely restricted. Asthma affects approximately 5 percent of the overall population, but the incidence is higher, about 1 in 10, in children. Asthma can develop at any age, but some children seem to outgrow the illness. Risk factors include self or family history of eczema, allergies or a family history of asthma.
Treatment generally takes a two-pronged approach consisting of 1) avoiding known allergens and 2) controlling symptoms through medication.
A variety of medications for treatment of asthma are available and include anti-inflammatory medications such as inhaled corticosteroids, oral or intravenous corticosteroids, and non-steroidal compositions such as nedocromil sodium. Also commonly prescribed are bronchodilators, both inhaled and orally administered, cromolyn sodium, which is used to prevent attacks, not for treatment during an attack, and aminophylline or theophylline.
People with mild asthma (infrequent attacks) are generally prescribed inhalers for use on an as-needed basis. Those with significant asthma (symptoms occur once per week or more) are generally treated with anti-inflammatory medications, such as inhaled corticosteroids, and then with bronchodilators for acute attacks. Severe acute asthma, left untreated, is known to require hospitalization, oxygen, and intravenous medications.
2. Description of the Related Art
Compositions for treating asthma are known in the art and generally comprise a pharmaceutical compound which is administered either via inhalation or oral ingestion, usually in tablet form. For example, U.S. Pat. No. 4,338,931 (Cavazza, C., Jul. 13, 1982), U.S. Pat. No. 5,301,666 (Lerk, C., et al., Apr. 12, 1994) and U.S. Pat. No. 5,823,183 (Casper, R. A., et al., Oct. 20, 1998) each disclose a method of administering a dry powder medicament directly to the lungs via inhalation.
U.S. Pat. No. 5,352,694 (Cuthbert, M. W., Oct. 4, 1994) discloses an orally administered pharmaceutical compound which is a leukotriene antagonist useful in treating conditions such as asthma.